🇺🇸 Probuphine in United States

FDA authorised Probuphine on 26 May 2016 · 130 US adverse-event reports

Marketing authorisation

FDA — authorised 26 May 2016

  • Application: NDA204442
  • Marketing authorisation holder: REACX PHARMS
  • Local brand name: PROBUPHINE
  • Indication: IMPLANT — IMPLANTATION
  • Status: approved

Read official source →

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Withdrawal Syndrome — 22 reports (16.92%)
  2. Incorrect Product Administration Duration — 14 reports (10.77%)
  3. Malaise — 13 reports (10%)
  4. Drug Ineffective — 12 reports (9.23%)
  5. Drug Withdrawal Syndrome — 12 reports (9.23%)
  6. Incorrect Drug Administration Duration — 12 reports (9.23%)
  7. Nausea — 12 reports (9.23%)
  8. Somnolence — 12 reports (9.23%)
  9. Fatigue — 11 reports (8.46%)
  10. Complication Of Device Removal — 10 reports (7.69%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Probuphine approved in United States?

Yes. FDA authorised it on 26 May 2016.

Who is the marketing authorisation holder for Probuphine in United States?

REACX PHARMS holds the US marketing authorisation.